Table 2.
Comparison of changes of laboratory and clinical parameters from baseline to week 2 between treatment groups.
| GG baseline | GG week 2 | TAU baseline | TAU week 2 | Δ GG | Δ TAU | Interaction | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| N | Mean | SD | N | Mean | SD | N | Mean | SD | N | Mean | SD | ||||
| Age, years | 12 | 37.3 | 10.9 | 12 | 37.3 | 10.9 | 55 | 44.6 | 15.7 | 55 | 44.6 | 15.7 | |||
| BMI, kg/m2 | 12 | 29.9 | 7.7 | 12 | 30.0 | 7.7 | 51 | 27.8 | 5.5 | 51 | 27.8 | 5.5 | |||
| TST, min | 12 | 409.9 | 81.5 | 11 | 344.2 | 96.8 | 53 | 392.8 | 72.0 | 48 | 391.1 | 80.1 | p < 0.08 | p < 0.05 | |
| Heart rate variability | 12 | 70.3 | 12.0 | 12 | 69.1 | 11.1 | 51 | 67.1 | 14.1 | 50 | 64.2 | 15.3 | p < 0.05 | ||
| Systolic BP, mmHg | 12 | 118.1 | 14.0 | 12 | 119.6 | 14.3 | 55 | 127.2 | 20.3 | 53 | 123.8 | 18.5 | p < 0.05 | ||
| Mg2+, mmol/l | 12 | 0.83 | 0.05 | 12 | 0.98 | 0.45 | 53 | 0.85 | 0.07 | 52 | 0.85 | 0.07 | p < 0.05 | ||
| Na+/K+ ratio | 12 | 37.5 | 3.2 | 12 | 38.2 | 3.4 | 53 | 37.6 | 3.1 | 51 | 37.1 | 3.3 | |||
| Aldosterone, pg/ml | 12 | 14.3 | 11.7 | 11 | 14.8 | 7.5 | 51 | 22.4 | 21.8 | 46 | 16.3 | 12.7 | |||
| Cortisol, ng/ml | 12 | 4.23 | 2.17 | 12 | 5.38 | 3.09 | 54 | 5.9 | 3.66 | 52 | 6.10 | 3.92 | |||
| HAMD-21 | 12 | 26.5 | 5.4 | 12 | 20.2 | 8.3 | 55 | 23.2 | 7.0 | 55 | 18.9 | 8.3 | p < 0.01 | p < 0.01 | p < 0.03 |
| HAMD (item 1) | 12 | 3.5 | 0.8 | 12 | 2.5 | 1.6 | 55 | 2.9 | 1.0 | 55 | 2.4 | 1.2 | p < 0.05 | p < 0.05 | p < 0.03 |
| CGI severity | 12 | 4.75 | 0.75 | 12 | 3.83 | 1.27 | 54 | 4.83 | 0.97 | 53 | 4.32 | 1.22 | p < 0.02 | p < 0.01 | p < 0.05 |
Δ GG and Δ TAU, significant difference from baseline (t-test); Interaction, significant interaction of treatment, corrected for gender and rater.
TST, total sleep time; BMI, body mass index, BP, blood pressure; HAMD, Hamilton Depression Rating Scale; CGI, clinical global impression.